Status:
COMPLETED
Combined THC and CBD Drops for Treatment of Crohn's Disease
Lead Sponsor:
Meir Medical Center
Conditions:
Crohn's Disease
Eligibility:
All Genders
20-85 years
Phase:
PHASE1
PHASE2
Brief Summary
There are many reports about efficacy of Cannabis in Crohn's disease but no controlled trials. The aim of the proposed trial is to investigate the efficacy of oil containing the cannabinoids THC and C...
Detailed Description
The investigators have recently published a retrospective observational study about the beneficial effect of cannabis in Crohn's disease. The investigators have also concluded a double blind placebo c...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of Crohn's disease of at least 3 months duration, which was proved by either endoscopy or appropriate imaging study.
- Patients who have failed treatment with either 5 ASA or corticosteroids or immunomodulators or biologic agents, or steroid dependant patients, or patients who were treated by the above mentioned drugs and could not tolerate them due to side effects.
- Age 20 or older.
- Able to sign informed concent
- Active Crohn's disease with a CDAI 200 or more.
- \-
Exclusion
- Patients with a diagnosis of a mental disorder
- Patients who by the judgment of their physician are likely to develop drug addiction.
- Pregnant women or women who are intending to become pregnant
- Patients with a known cannabis allergy
- Patients who are not capable of giving an informed consent
- Patients with an impending operation due to Crohn's disease.
- \-
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01826188
Start Date
March 1 2013
End Date
June 1 2018
Last Update
March 8 2019
Active Locations (1)
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1
Meir Hospital
Kfar Saba, Israel